This trial is active, not recruiting.

Condition pancreatic cancer
Treatment vegfr1-1084, vegfr2-169, and gemcitabine
Phase phase 1
Sponsor Fukushima Medical University
Collaborator Human Genome Center, Institute of Medical Science, University of Tokyo
Start date March 2007
End date March 2013
Trial size 5 participants
Trial identifier NCT00639925, FPCR1R2-1


The purpose of this study is to evaluate the safety, and tolerability of HLA-A*2402 restricted epitope peptide VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination with gemcitabine

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
vegfr1-1084, vegfr2-169, and gemcitabine
One mg of each peptide will be administered by subcutaneous injection on days 1, 8, 15, and 22 of each 28-day treatment cycles. Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 1, 8 and 15.

Primary Outcomes

Adverse effect, toxicities as assessed by NCI CTCAE version3.0
time frame: 3 months

Secondary Outcomes

time frame: 2 years

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

Inclusion Criteria: DISEASE CHARACTERISTICS 1. Locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer 2. Measurable disease by CT scan PATIENTS CHARACTERISTICS 1. ECOG performance status 0-2 2. Life expectancy > 3 months 3. Laboratory values as follows 2,000/mm3 < WBC < 15000/mm3 Platelet count ≥ 750,000/mm³ Total Bilirubin ≤ 1.5 x Aspartate transaminase < 150 IU/L Alanine transaminase < 150 IU/L Creatinine ≤ 3.0 mg/dl 4. HLA-A*2402 5. Able and willing to give valid written informed consent Exclusion Criteria: 1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) 2. Breast-feeder 3. Active or uncontrolled infection 4. Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks 5. Serious or aggravated wound 6. Active or uncontrolled other malignancy 7. Steroids or immunosuppressing agent dependant status 8. Interstitial pneumonia 9. Ileus 10. Decision of unsuitableness by principal investigator or physician-in-charge

Additional Information

Official title Phase I Sturdy on Antiangiogenic Vaccine Therapy Using Epitope Peptide Derived From VEGFR1 and VEGFR2 With Gemcitabine in Treating Patients With Unresectable, Recurrent, or Metastatic Pancreatic Cancer
Description Vascular endothelial growth factor receptor 1 and 2 (VEGFR1 andVEGFR2) are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and in vivo. According to these findings, in this trial, we evaluate the safety, tolerability and immune response of these peptide emulsified with Montanide ISA 51 in combination with gemcitabine
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Fukushima Medical University.